Cleared Traditional

K142567 - RETeval Visual Electrodiagnostic Device

K142567 is an FDA 510(k) clearance for RETeval Visual Electrodiagnostic Device, manufactured by Lkc Technologies, Inc.. The device is a Class 2 Neurology device with product code GWE cleared through the Traditional 510(k) pathway after a 249-day FDA review.

K142567 · Lkc Technologies, Inc. · Neurology device
Download Printable Device Report (PDF)
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May 2015
Decision
249d
Days
Class 2
Risk

K142567 is an FDA 510(k) clearance for the RETeval Visual Electrodiagnostic Device. Classified as Stimulator, Photic, Evoked Response (product code GWE), Class II - Special Controls.

Submitted by Lkc Technologies, Inc. (Gaithersburg, US). The FDA issued a Cleared decision on May 19, 2015 after a review of 249 days - an extended review cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.1890 - the FDA neurology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Neurology review framework, consistent with the majority of Class II 510(k) submissions.

View all Lkc Technologies, Inc. devices

FDA 510(k) Submission Details - K142567

510(k) Number K142567 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 12, 2014
Decision Date May 19, 2015
Days to Decision 249 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
101d slower than avg
Panel avg: 148d · This submission: 249d
Pathway characteristics
Predicate-based equivalence.

GWE Device Classification - Class 2, Special Controls

Product Code GWE Stimulator, Photic, Evoked Response
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.1890
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. Clinical trial data may be submitted as supporting evidence to strengthen the substantial equivalence argument. Most Neurology devices follow this clearance model.

Regulatory Consultant

Regulatory Affairs Associates, Inc.
Stephen J. Goldner

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Clinical Evidence

ClinicalTrials.gov
NCT01950663 Completed Interventional Industry-sponsored

RETeval Study for Diabetic Retinopathy

RETeval Calibration / Validation Study - Diabetic Retinopathy

468
Patients (actual)
2
Sites
Diagnostic
Purpose
Open label
Masking
Condition studied Diabetic Retinopathy
Study design Single group
Eligibility All sexes · 18 Years+
Principal investigator Stephen R Fransen, MD
Sponsor Inoveon Corporation (industry)
Started 2013-09-01 → Primary completion 2014-04-01
Primary outcome
Per Patient Referral Accuracy
View full study on ClinicalTrials.gov

Regulatory Peers - GWE Stimulator, Photic, Evoked Response

All 28
Devices cleared under the same product code (GWE) and FDA review panel - the closest regulatory comparables to K142567.
Vision Monitor - MonpackONE
K211643 · Metrovision · Jul 2021
Nurochek System
K200705 · Cryptych Pty, Ltd. · Apr 2020
Natus Photic Stimulator
K173936 · Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek) · Jun 2018
ADHERENT VISUAL STIMULATOR GOGGLES
K113785 · Anschel Technology, Inc. · Jun 2012
VISIONSEARCH 1
K120104 · Visionsearch Pty, Ltd. · May 2012
GLAID OCULAR ELECTROPHYSIOLOGY DEVICE
K043367 · Lace Electronica S.R.L. · Nov 2005